Trial Outcomes & Findings for Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer (NCT NCT00871858)

NCT ID: NCT00871858

Last Updated: 2021-02-24

Results Overview

Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0. Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 120 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2021-02-24

Participant Flow

Participant milestones

Measure	Arm A (ANA) Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months. anastrozole: Given orally	Arm B (FULV) Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months. fulvestrant: Given intramuscularly
Overall Study STARTED	61	59
Overall Study Evaluable for Safety	60	58
Overall Study COMPLETED	56	52
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Measure	Arm A (ANA) Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months. anastrozole: Given orally	Arm B (FULV) Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months. fulvestrant: Given intramuscularly
Overall Study Protocol Violation	3	4
Overall Study Adverse Event	1	1
Overall Study Withdrawal by Subject	1	1
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer

Baseline characteristics by cohort

Measure	Arm A (ANA) n=61 Participants Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months. anastrozole: Given orally	Arm B (FULV) n=59 Participants Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months. fulvestrant: Given intramuscularly	Total n=120 Participants Total of all reporting groups
Age, Continuous	69.1 years n=113 Participants	70.5 years n=163 Participants	69.8 years n=160 Participants
Sex: Female, Male Female	61 Participants n=113 Participants	59 Participants n=163 Participants	120 Participants n=160 Participants
Sex: Female, Male Male	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Region of Enrollment France	61 participants n=113 Participants	59 participants n=163 Participants	120 participants n=160 Participants

PRIMARY outcome

Timeframe: 6 months

Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.

Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).

Outcome measures

Measure	Arm A (ANA) n=56 Participants Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months. anastrozole: Given orally	Arm B (FULV) n=52 Participants Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months. fulvestrant: Given intramuscularly
Objective Response Rate (ORR) Determined by Clinical Palpation	58.9 percentage of participants Interval 45.0 to 71.9	53.8 percentage of participants Interval 39.5 to 67.8

SECONDARY outcome

Timeframe: 6 months

Population: Out of 108 patients (56 arm A + 52 arm B) evaluable for efficacy ("completed" in flow chart) : 19 patients in Arm A and 31 in arm B with missing size at ultrasound examination

Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.

Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).

Outcome measures

Measure	Arm A (ANA) n=37 Participants Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months. anastrozole: Given orally	Arm B (FULV) n=21 Participants Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months. fulvestrant: Given intramuscularly
Objective Response Rate (ORR) Determined by Ultrasound	35.1 percentage of participants Interval 20.2 to 52.5	52.4 percentage of participants Interval 29.8 to 74.3

SECONDARY outcome

Timeframe: 6 months

Population: Out of 108 patients (56 arm A + 52 arm B) evaluable for efficacy ("completed" in flow chart) : 33 patients in Arm A and 34 in arm B with missing size at mammography.

Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0.

Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).

Outcome measures

Measure	Arm A (ANA) n=23 Participants Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months. anastrozole: Given orally	Arm B (FULV) n=18 Participants Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months. fulvestrant: Given intramuscularly
Objective Response Rate (ORR) Determined by Mammography	26.1 percentage of participants Interval 10.4 to 48.4	27.8 percentage of participants Interval 9.7 to 53.5

SECONDARY outcome

Timeframe: 6 months

breast-conserving surgery concerns patients who did not undergo mastectomy.

Outcome measures

Measure	Arm A (ANA) n=56 Participants Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months. anastrozole: Given orally	Arm B (FULV) n=52 Participants Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months. fulvestrant: Given intramuscularly
Rate of Breast-conserving Surgery	60.7 percentage of participants Interval 46.8 to 73.5	50.0 percentage of participants Interval 35.8 to 64.2

SECONDARY outcome

Timeframe: 5 years

Relapse-Free survival (RFS) is measured from the date of randomization to the date of the following events, whichever occurs first according to the DATECAN recommendations for breast cancer:

• Invasive ipsilateral breast tumor recurrence/ progression ;
• Local invasive recurrence/progression ;
• Regional invasive recurrence/progression (N+: regional progression) ;
• Appearance/Occurrence of Metastatic recurrence;
• Death whatever the cause.

Participants who did not experience events were censored at the date of last follow-up. RFS was estimated using the Kaplan-Meier method. No comparison test was performed between the two arms as this study is non-comparative.

Outcome measures

Measure	Arm A (ANA) n=56 Participants Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months. anastrozole: Given orally	Arm B (FULV) n=52 Participants Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months. fulvestrant: Given intramuscularly
Percentage of Participants With 5-year Relapse-Free Survival	82.8 Percentage of participants Interval 69.6 to 90.7	74.7 Percentage of participants Interval 60.4 to 84.5

Adverse Events

Arm A (ANA)

Serious events: 2 serious events

Other events: 48 other events

Deaths: 6 deaths

Arm B (FULV)

Serious events: 3 serious events

Other events: 43 other events

Deaths: 6 deaths

Serious adverse events

Measure	Arm A (ANA) n=60 participants at risk Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months. anastrozole: Given orally	Arm B (FULV) n=58 participants at risk Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months. fulvestrant: Given intramuscularly
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell kidney cancer	0.00% 0/60	1.7% 1/58 • Number of events 1
Infections and infestations Bronchial infection	0.00% 0/60	1.7% 1/58 • Number of events 1
Injury, poisoning and procedural complications Ankle fracture	1.7% 1/60 • Number of events 1	0.00% 0/58
Reproductive system and breast disorders Endometrial atrophy	0.00% 0/60	1.7% 1/58 • Number of events 1
Renal and urinary disorders Programmed peritoneal dialysis	1.7% 1/60 • Number of events 1	0.00% 0/58

Other adverse events

Measure	Arm A (ANA) n=60 participants at risk Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months. anastrozole: Given orally	Arm B (FULV) n=58 participants at risk Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months. fulvestrant: Given intramuscularly
General disorders Fatigue	11.7% 7/60 • Number of events 7	32.8% 19/58 • Number of events 20
Investigations Weight gain	5.0% 3/60 • Number of events 3	3.4% 2/58 • Number of events 2
General disorders Injection site reaction	0.00% 0/60	15.5% 9/58 • Number of events 9
Vascular disorders Hot flashes	21.7% 13/60 • Number of events 13	24.1% 14/58 • Number of events 14
Gastrointestinal disorders Nausea	6.7% 4/60 • Number of events 4	3.4% 2/58 • Number of events 2
Nervous system disorders Dizziness	5.0% 3/60 • Number of events 3	3.4% 2/58 • Number of events 2
Psychiatric disorders Agitation	5.0% 3/60 • Number of events 3	6.9% 4/58 • Number of events 4
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 20/60 • Number of events 20	19.0% 11/58 • Number of events 11
Musculoskeletal and connective tissue disorders MYALGIA	3.3% 2/60 • Number of events 2	5.2% 3/58 • Number of events 3

Additional Information

Dr. Nathalie Quenel-Tueux

Institut Bergonié, Medical Oncology department

Phone: 05.56.33.33.33

Email: N.Quenel-Tueux@bordeaux.unicancer.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place